Psoriasis: FAEs demonstrate long-term safety, efficacy

  • Dickel H & al.
  • J Eur Acad Dermatol Venereol
  • 28 Apr 2018

  • curated by Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • A retrospective analysis suggests that fumaric acid esters (FAEs) are safe and beneficial for long-term systemic treatment of patients with moderate-to-severe psoriasis.

Why this matters

  • This study provides needed data on long-term maintenance treatments for patients with moderate-to-severe psoriasis.

Key results

  • Median time to a 50% response rate (cumulative static Physician’s Global Assessment [PGA] score of “light” and ≥2-point reduction in baseline PGA) was 1 year for each cohort (FAE monotherapy, concomitant phototherapy, and concomitant methotrexate; P=.70 for differences among cohorts).
  • Median time to 50% response rate for cumulative Psoriasis Area and Severity Index (PASI) 75 was 3 years for the FAE monotherapy cohort, 6.7 years for the concomitant phototherapy cohort, and 8.1 years in the concomitant methotrexate cohort (P=.001).
  • 49.0% of patients experienced adverse events:
    • 3.5% reported serious adverse events;
    • 12.9% experienced adverse events leading to treatment discontinuation.

Study design

  • 859 patients with moderate-to-severe psoriasis (626 received FAE monotherapy; 123 received FAEs with concomitant phototherapy; 110 received FAEs with methotrexate) were analyzed for response rates for up to 32.5 years of follow-up.
  • Funding: Biogen GmbH.

Limitations

  • Retrospective study from a single center.

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